NYSE:CVM
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First Quarter Fiscal Year 2024 Update
CEL-SCI Corporation (NYSE:CVM) reported its fiscal 1Q:24 on February 7, 2024 with the submission of its Form 10-Q with the SEC followed by a press release. Subsequently, news was released regarding its secondary LEAPS candidate, a capital raise and the manufacturing facility. In the European Union, CEL-SCI was granted a waiver of pediatric requirements. Last December, Multikine was evaluated as a new standard of care in the UK. Health Canada advised the company to request advance consideration and, along with the FDA, was awaiting target population data. CEL-SCI has also commissioned its Multikine manufacturing facility near Baltimore, Maryland and raised additional funds in a public offering. The LEAPS vaccine program also had a day in the sun as a paper examining the candidate’s role in rheumatoid arthritis was published in Frontiers of Immunology.
Financial Review
CEL-SCI recognized no revenues for its fiscal first quarter ending December 31, 2023 and incurred operating expenses totaling $6.5 million during the three-month period. This resulted in a net loss available to common shareholders of ($6.7) million, or ($0.14) per share.
For the quarter ending December 31, 2023 versus the same prior year period:
➢ Expenses for research and development fell 19% to $4.4 million from $5.4 million. Lower pre-commercialization, Phase III study, and employee stock compensation costs contributed to the decrease;
➢ General and administrative expenses declined 6% to $2.1 million from $2.3 million on lower consulting fees and employee stock compensation expense partially offset by an increase in miscellaneous administrative expenses;
➢ Other non-operating items were ($26,000) compared to ($222,000) in the prior year;
➢ Net interest expense of ($0.2) million compared with ($0.2) million;
➢ Net loss totaled ($6.7) million versus ($8.0) million or ($0.14) and ($0.18) per share, respectively.
As of December 31, 2023, cash and equivalents totaled $3.2 million. Cash burn for the three-month period amounted to approximately ($5.0) million, up from last year’s ($4.7) million. In fiscal 2Q:24, CEL-SCI raised approximately $7.8 million in a common stock offering. CEL-SCI holds no debt on its balance sheet.
EMA Waives Pediatric Requirements
As part of its ongoing application process in the EU, CEL-SCI was able to obtain a waiver for conducting further studies in the pediatric population for Multikine in Squamous Cell Carcinoma of the Head and Neck (SCCHN). All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver.
A pediatric waiver from the European Medicines Agency (EMA) allows a pharmaceutical company to be exempt from having to conduct studies in the pediatric population. The main benefit of the pediatric waiver is that it reduces the burden of conducting potentially unnecessary pediatric studies, which can be costly, time-consuming, and may unnecessarily expose children to an investigational medicine. Pediatric waivers are typically granted when the medicine is intended to treat a condition that affects the adult population, the investigational product does not provide a significant benefit to pediatric patients or the disease does not occur in the pediatric population. The waiver will help CEL-SCI avoid substantial time and cost burdens while still allowing Multikine to be used in the target population if approved.
LEAPS Article Published in Frontiers in Immunology
The scientific journal Frontiers in Immunology published an article in its March 2024 issue on CEL-SCI’s Ligand Epitope Antigen Presentation System (LEAPS) technology as reported in a March 19th press release. While there are approved treatments for rheumatoid arthritis (RA) including adalimumab and other TNF blockers and JAK inhibitors they do not balance adaptive immune homeostasis. These classes of drugs also present the risk of stimulating other disease. CEL-SCI’s CEL-4000 therapeutic vaccine may be able to treat RA while limiting negative side effects by promoting antigen-specific regulatory rather than inflammatory responses, thereby modulating the immunopathological course of RA. In CEL-SCI’s article entitled Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines, the authors discuss in-development and approved products for the disease and preclinical data for CEL-4000. CEL-SCI’s candidate is able to redirect autoreactive pro-inflammatory memory T cells towards rebalancing the runaway immune/inflammatory responses that characterize the disease. The drug’s features require the use of more advanced trial design such as adaptive trials and the use of biomarkers for endpoints. The article concludes by asserting that an antigen-specific immunomodulating vaccine, such as CEL-4000, may deliver therapy for RA without weakening important immune defense mechanisms against microbial infections or cancer.
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